A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Thioridazine Indications, Dosage, Storage, Stability - Thioridazine
Thioridazine Indications, Dosage, Storage, Stability - Thioridazine
INDICATIONS
For the management of manifestations of psychotic
disorders.
For the short- term treatment
of moderate to marked depression
with variable degrees of anxiety
in adult patients and
for the treatment
of multiple symptoms such
as agitation, anxiety,
depressed mood, tension,
sleep disturbances, and fears in geriatric patients.
For the treatment
of severe behavioral problems in children marked by combativeness
and/or explosive hyperexcitable behavior
(out of proportion to immediate
provocations), and in the short-term treatment
of hyperactive children who show
excessive motor activity
with accompanying conduct disorders consisting of some or all of
the following symptoms: impulsivity, difficulty sustaining attention,
aggressivity, mood lability,
and p.o. frustration tolerance.
DOSAGE AND ADMINISTRATION
Dosage must be individualized according to the degree
of mental and emotional
disturbance. In all cases,
the smallest effective dosage
should be determined for each patient.
Adults
Psychotic manifestations: The usual starting dose
is 50 to 100 mg three times
a day, with a gradual increment
to a maximum of 800
mg daily if necessary. Once effective control
of symptoms has been achieved, the dosage
may be reduced gradually to determine the minimum
maintenance dose. The total daily dosage
ranges from 200 to 800 mg
divided into two to four doses.
For the short-term treatment
of moderate to marked depression
with variable degrees of anxiety
in adult patients and
for the treatment
of multiple symptoms such
as agitation, anxiety,
depressed mood, tension,
sleep disturbances, and fears in geriatric patients: The usual
starting dose is 25 mg three
times a day. Dosage ranges from 10 mg
two to four times a day in milder cases to 50 mg
three or four times a day for more severely disturbed patients.
The total daily dosage
range is from 20 mg
to a maximum of 200 mg.
Children
Thioridazine is not intended for children under 2 years of age.
For children aged 2 to
12 the dosage of thioridazine
hydrochloride
ranges from 0.5 mg to a maximum
of 3 mg/kg per day. For
children with moderate disorders 10 mg
two or three times a day is the usual starting dose. For hospitalized,
severely disturbed, or psychotic
children, 25 mg two or three
times daily is the usual starting dose. Dosage may be increased
gradually until optimum therapeutic effect
is obtained or the maximum
has been reached.
HOW SUPPLIED
Thioridazine Hydrochloride Tablets, USP are available containing
10 mg, 25 mg, 50 mg, or 100 mg
of thioridazine hydrochloride.
The 10 mg tablets are orange,
round, unscored film coated
tablets marked with "M54" on one side
and "10" on the other side. They are available as follows:
NDC 0378-0618-01 bottles of 100 tablets
NDC 0378-0618-10 bottles of 1000 tablets
STORE AT CONTROLLED ROOM TEMPERATURE 15°- 30° C (59°-
86° F).
PROTECT FROM LIGHT.
Dispense in a tight, light-resistant container
using a child-resistant closure.
Rx Only
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